BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1860454 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14954
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    May 7, 2010
    Report Date
    July 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE SEALPLUGS WERE REMOVED. ALL SETSCREW THREADS AND TERMINAL BLOCK ARE EXTREMELY CLEAN AND ALL THREADS ARE VERY SHARP. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. INITIAL ALLEGATIONS OF NOISE, AND DIFFICULTY FIXING THE LEAD IN THE CONNECTOR PORT WERE NOT CONFIRMED BY LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISY SIGNALS ON THE PROGRAMMER SCREEN WHEN THE PHYSICIAN MOVED THE LEAD. IT WAS ALSO NOTED THE LEAD DID NOT STAY FIXED IN THE CONNECTOR PORT. THE PHYSICIAN ELECTED EXPLANT THIS ICD, AND IMPLANT A NEW DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1